Atlas

Form 483

Vertex Pharmaceuticals Incorporated Form 483, 2012-01-13

FDA issued a Form 483 to Vertex Pharmaceuticals Incorporated on 2012-01-13 with 2 public-safe observations.

483· Form 483 issued2 observations

Vertex Pharmaceuticals Incorporated · Boston, United States · Issued January 13, 2012

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

13 Jan 2012
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Robert J Martin

13 Jan 2012
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Robert J Martin

Inspected site

VPVertex Pharmaceuticals IncorporatedBoston, United States

Inspection team

RJRobert J Martin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere